Radiologically trackable surgical sponges

ABSTRACT

The apparatus and method is provided that employs a “radiopaque” object to count and account for surgical sponges in an operating room. A radiopaque object is embedded in surgical sponges so that a scanning device can detect and count a large number of the sponges within a container. The container is designed to minimize contact with the sponges by humans. In addition, a surgical team can insure that no surgical sponge is left in a patient without performing the messy and time-consuming job of individually counting sponges as they are entered and disposed of from the surgical site.

RELATED APPLICATIONS

This application is a continuation of application Ser. No. 10/124,534,filed on Apr. 17, 2002, and entitled “System and Method of TrackingSurgical Sponges.”.

BACKGROUND

1. Technical Field

The invention relates generally to an apparatus and method for trackingsurgical supplies and, more specifically, to counting and accounting forall disposable surgical sponges used in a surgical procedure.

2. Related Art

During surgical procedures, absorbent sponges are employed to soak upblood and other fluids in and around the incision site. In a studyentitled “The Retained Surgical Sponge” (Kaiser, et al., The RetainedSurgical Sponge, Annals of Surgery, vol. 224, No. 1, pp. 79-84),surgical sponges were found to have been left inside a patient followingsurgery in 67 of 9729 (0.7%) medical malpractice insurance claimsreviewed. In those 67 cases, the mistake was attributed to an incorrectsponge count in seventy-six percent (76%) of the cases studied, andattributed to the fact that no count was performed in ten percent (10%)of the cases studied. Typically, a sponge left inside a patient ispresumed to indicate that substandard and negligent care has takenplace. Clearly, it is in both a patient's and the health care providers'best interest to account for every surgical sponge used in anyparticular surgical procedure.

As explained in U.S. Pat. No. 5,923,001 entitled Automatic SurgicalSponge Counter and Blood Loss Determination System, sponge counts are anessential step in operating room procedure. Sponge counts are adifficult procedure for a number of reasons. For example, the handlingof soiled sponges carries the risk of transmission of blood bornediseases such as hepatitis B virus (HBV) and human immunodeficiencyvirus (HIV). Therefore, used sponges are handled with gloves and/orinstruments and the handling is kept to a minimum. Another difficulty isthat the counting process is typically tedious, time-consuming andfrustrating.

Sponge counts are typically performed multiple times during a surgicalprocedure, both at the beginning and throughout the procedure as spongesare added, before closure of a deep incision or body cavity, and duringpersonnel breaks and shift changes. Thus, within all the activity of anoperating room, maintaining an accurate sponge is difficult, asevidenced by the error rate mentioned in the Keiter article, quotedabove.

There do exist products to make the procedure both simpler and morereliable. For example, various systems facilitate the hand-counting ofsurgical sponges by arranging the sponges into visually inspectiblegroups or arrangements (see U.S. Pat. No. 3,948,390, No. 4,364,490, No.4,784,267, No. 4,832,198, No. 4,925,048 and No. 5,658,077). Thesesystems are problematic because surgeons and anesthesiologists oftendetermine blood loss by means of visual inspection or a manual weighingof soiled sponges and so soiled sponges are typically kept in one areaof an operating room during a surgical procedure, thus creating thepossibility that groupings are co-mingled or counted twice. In addition,operating room workers are often too rushed, fatigued and/or distractedto accurately count a large number of soiled sponges lumped together inone or more groups. This method also depends upon the accuracy of aninitial count and, if the number of sponges in the original package ismislabeled by the manufacturer, then a missing sponge may be missedduring a final count.

A second solution to the surgical sponge tracking problem is theinclusion of a radiopaque thread in the sponges. A radiopaque thread canbe identified and located if a sponge is accidentally left inside apatient. Thus, if a patient develops a problem such as an abscess, abowel obstruction, or internal pain at any time following an operation,a sponge that has been left in the body can be detected by x-ray.Companies that market sponges with radiopaque threads include Johnson &Johnson, Inc. of New Brunswick, N.J., Medline Industries of Mundelein,Ill. and the Kendall Company of Mansfield, Mass.

A third solution to the sponge problem is the inclusion of a radiofrequency identification (RFID) tag in each sponge (see U.S. Pat. No.5,923,001). The RFID tag enables a patient to be scanned to detect thepresence of a sponge within a body cavity, but RFID tags may costseveral times what a typical surgical sponge costs and are also bulky,impairing the usefulness of the sponge.

Another solution to the sponge problem is a device that counts spongesas they are dropped, one-by-one, into an opening, or “entry gate,” ofthe device (see U.S. Pat. No. 5,629,498). This solution is restricted bythe accuracy of the original count and the precision of operating roomassistants as they separate sponges from one another and drop them intothe entry gate, one-by-one.

A final, exemplary solution involves attaching a magnetic resonancedevice, or marker tag, to each sponge, which are then scanned byappropriate equipment (see U.S. Pat. No. 5,057,095 and No. 5,664,582).The problem with this solution is that both the marker tags and thescanning equipment are expensive and do not necessarily work well in anoperating room environment. As acknowledged in the '582 patent, thescanner must be essentially parallel to the marker tag inside a waddedup sponge. If the marker tag is bent or folded, a signal from the tagmay be difficult to identify. In addition, the scanning equipment maygive false counts if the operating room contains objects, other than themarker, that also generate or respond to magnetic energy.

Many other problems and disadvantages of the prior art will becomeapparent to one skilled in the art after comparing such prior art withthe present invention as described herein.

SUMMARY OF THE INVENTION

The apparatus and method provided employ a “radiopaque” object to countand account for surgical sponges in an operating room. The term“radiopaque” refers to an object that is detectable by a scanning deviceusing an x-ray or other penetrating wave or particle such as neutronbeams or gamma rays, and infrared, near-infrared, laser, electromagneticor radio waves. Within the context of the claimed subject matter, a“surgical sponge” is any device or material used in human or animalsurgery for the purpose of absorbing blood or other fluids, or forpacking off, containing, or isolating bodily structures within asurgical field.

A radiopaque object is embedded in each surgical sponge so that ascanning device can detect and count a large number of the spongeswithin a container designed to eliminate the need for contact by humanswith the sponges. In this manner, a surgical team can insure that nosurgical sponge is left in a patient without performing the messy andtime-consuming job of individually counting sponges as they are enteredand removed from the surgical site.

The claimed subject matter includes specially designed surgical spongesfor use in the scanning device. Also included in the claimed subjectmatter is the use of radiopaque objects of differing sizes and/or typesembedded in surgical sponges of differing sizes and/or types. Forexample, a large sponge may contain a large object and a small spongemay contain a small object so that the scanning device can distinguishand count multiple sizes and types of sponges. In one embodiment of theinvention, the scanning device also weighs discarded surgical sponges sothat a calculation can be made of the sponges' retained fluids, i.e.patient fluid loss.

Other systems, methods, features and advantages of the invention will beor will become apparent to one with skill in the art upon examination ofthe following figures, which are not necessarily drawn to scale, anddetailed description. It is intended that all such additional systems,methods, features and advantages be included within this description, bewithin the scope of the invention, and be protected by the accompanyingclaims.

BRIEF DESCRIPTION OF THE FIGURES

While various embodiments of the invention have been described, it willbe apparent to those of ordinary skill in the art that many moreembodiments and implementations are possible that are within the scopeof this invention.

FIG. 1 is an exemplary surgical supply tracking system (SSTS) employingthe techniques of the claimed subject matter.

FIG. 2 is an exemplary PC-based SSTS employing the techniques of theclaimed subject matter.

FIG. 3 is an illustration of a surgical sponge in relation to aradiopaque object according to the claimed subject matter.

FIG. 4 is an illustration of an exemplary surgical sponge in which theradiopaque object is woven or glued into the surgical sponge.

FIG. 5 is an illustration of an exemplary surgical sponge in which theradiopaque object is affixed to the surgical sponge by means of afixture patch.

FIG. 6 is an illustration of an exemplary surgical sponge in which theradiopaque object is affixed to the surgical sponge by means of afixture thread.

FIG. 7 is an illustration of an exemplary surgical sponge in which theradiopaque object is affixed to the surgical sponge by means of both afixture patch and a fixture thread.

FIG. 8 is a flowchart that illustrates the processing performed by theSSTS.

DETAILED DESCRIPTION OF THE FIGURES

Although described with particular reference to a system for trackingsurgical supplies within an operating room, the surgical supply trackingsystem (SSTS) of the disclosed subject matter can be implemented in anysystem in which it is desirable to count and/or track objects with aminimum of handling and a very high degree of accuracy.

Selected portions of the SSTS can be implemented in software, hardware,or a combination of hardware and software. Hardware portions of theinvention can be implemented using specialized hardware logic. Softwareportions can be stored in a memory and executed by a suitable computingsystem such as a microprocessor or a personal computer (PC).Furthermore, software of the SSTS, which comprises an ordered listing ofexecutable instructions for implementing logical functions, can beembodied in any computer-readable medium for use by or in connectionwith the computing system.

Turning now to the figures, FIG. 1 illustrates an exemplary SSTS 100 foruse in an operating room. A sponge container 101 includes a disposalopening 105 through which surgical sponges, such as a surgical sponge111, are placed after use. For the purposes of this disclosure, a“surgical sponge” is any device or material used in either human oranimal surgery for the purpose of absorbing blood or fluids, or forpacking off, containing, or isolating bodily structures within asurgical field. The sponge container 101 includes rollers 115 tofacilitate its movement within and outside the operating room. Bypressing a foot pedal 109, a user of the SSTS 100 opens a door (notshown) in the disposal opening 105 so that the used surgical sponge 111can be placed into the sponge container 101. In addition, the pressingof the foot pedal 109 causes hardware and/or software logic (not shown)in the SSTS 100 to activate a radiation source 103. The hardware and/orsoftware logic, with input from a sensor (not shown), then calculatesthe number of sponges in the sponge container 101. Once the hardwareand/or software logic has calculated the number of sponges in the spongecontainer 101, this number is displayed on a display 107. It should beapparent to those with skill in the electronic arts that the hardwareand/or software logic of the SSTS 100 can be implemented in a number ofways, including, but not limited to, specialized circuits incorporatingboth hardware and software components.

The sponge container 101 also includes a clear plastic covering (notshown) such as a plastic bag or a form-fitted covering that fits intothe disposal opening 105, thus containing the surgical sponges 111, anddrapes over the outside of the container 101 in order to keep fluidsfrom the surgical sponges 111 from contaminating the surface of thecontainer 101 and its components. In addition to the number of spongesin the container 101, the display 107 may also display a calculation ofthe weight of the contained sponges so that operating room personnel candetermine patient fluid loss. A set of user controls 113 are employed toturn the SSTS 100 on or off, initiate the display 107 and calibrate thesensors. In alternative embodiments of the SSTS 100, the calculation ofthe sponges in the container 101 and the display of this number may alsobe initiated by the user controls 113 rather than, or in addition to,the depression of the foot pedal 109.

FIG. 2 illustrates an exemplary PC-based SSTS 200 employing thetechniques of the claimed subject matter. The SSTS 200 includes a spongecontainer 201 in which surgical sponges, such as the surgical sponge 111(FIG. 1), can be disposed following the sponge's 111 use in a surgicalprocedure. The container 201 is positioned on a platform 221 that isconnected via a connection 223 to a radiation source 203, which issimilar to the radiation source 103 (FIG. 1). The platform may alsoinclude a weight sensor (not shown) for measuring the weight of thecontainer 201 and its contents. The platform 221 is also connected via aconnection 207 to a computing system 209. The connections 223 and 207may be hard-wired, wireless or network connections. In this example, thecomputing system 209 includes a processor 213, a display 215, a keyboard217 and a mouse 219. The exact configuration of the computing system 209is not critical to the spirit of the invention. For example, all orportions of the computing system 209 may be incorporated into theplatform 221 in order to provide a compact and integrated system withfewer discrete pieces than the illustrated system 200.

The radiation source 203 emits a scanning beam 205 that enablesdetectors (not shown) in the platform to detect a small radiopaqueobject 301 (see FIGS. 3-7) in each sponge 111 in the container 201. Theterm “radiopaque” means the object 301 is able to obscure or block sometype of scanning beam 205 such as x-ray or other penetrating wave orparticle such as neutron beams, gamma rays, infrared, near-infrared,laser, electromagnetic waves or radio waves. The specific type ofscanning beam 205 is not critical to the spirit of the inventions otherthan that the detectors in the platform 201 must be able to detect thescanning beam 205 with sufficient resolution to count each radiopaqueobject 301 in each sponge 111 in the container 101. As with thecomputing system 209, the radiation source 203 and the platform may beintegrated into a single device, in which case the SSTS 200 would lookmore like the SSTS 100 (FIG. 1).

FIG. 3 is an illustration of a surgical sponge 311 (FIG. 1) in relationto a radiopaque object 301. The surgical sponge 311 is one embodiment ofthe surgical sponge 111 (FIGS. 1 and 2). The surgical sponge 311 iscomprised of an absorbent material 307 contained within vertical threads303 and horizontal threads 305. Other examples of suitable surgicalsponges include foam sponges or other sponges made of non-woven,non-knitted or non-fabric material. The surgical sponge 311, except forthe radiopaque object 301, should be familiar to those with experiencewith surgery and the equipment employed in surgery. Although notnecessarily drawn to scale, the radiopaque object 301 is small inrelation to the surgical sponge 311. Typically, the radiopaque object301 is less than one (1) centimeter wide in any direction. Although, theradiopaque object 301, illustrated in FIG. 3, is a metal sphere therecan be different types of radiopaque objects; i.e., many differentshapes and materials can be employed. For example, the radiopaque object301 may be cylindrical, cubic, rectangular, triangular or some otherpolygon, either regularly or irregularly shaped. The radiopaque object301 may also be some other shape such as a hexagonal nut, either with orwithout a hole in the middle. Different types of radiopaque objects canbe used to indicate different types or sizes of surgical sponges. Inaddition, the radiopaque object may be something other than metal. Forexample, the object 301 may be barium sulfate encased in anon-water-soluble material such as plastic, latex, rubber, silicone orsilastic, or even encased in a tightly woven fabric.

FIGS. 4-7 show alternative methods of affixing a radiopaque object, suchas the radiopaque object 301, to a surgical sponge, such as surgicalsponges 111 and 311. FIG. 4 is an illustration of an exemplary surgicalsponge 411 with a radiopaque object 401 woven or glued into the surgicalsponge 411. In other words, the radiopaque object 401 is held betweenvertical threads 403 and horizontal threads 405 by means of a secondlayer of vertical threads 413 and a second layer of horizontal threads415 and/or glued into the surgical sponge 411. FIG. 5 is an illustrationof an exemplary surgical sponge 511 with a radiopaque object 501 affixedby means of a fixture patch 507. The fixture patch 507 is a piece oflatex, tape or fabric mesh that firmly attaches by means of sewing,gluing or weaving to the radiopaque object 501 and either or both ofthreads 503 and 505 and absorbent material 509. FIG. 6 is anillustration of an exemplary surgical sponge 611 with a radiopaqueobject 601 affixed by means of a fixture thread 607. The fixture thread607 can be either tied to, threaded through or clamped by the radiopaqueobject 601 and then woven into vertical and horizontal threads 603 and605. FIG. 7 is an illustration of an exemplary surgical sponge 711 witha radiopaque object 701 affixed by means of both a fixture patch 707,similar to the fixture patch 507 (FIG. 5) and a fixture thread 709,similar to the fixture thread 607 (FIG. 6).

FIG. 8 is a flowchart of a Count Sponge process 800 executed by eitherthe SSTS 100 of FIG. 1 or the SSTS 200 of FIG. 2. The process 800 startsin a Begin Scan step 801 and proceeds immediately to an Activate ScanBeam step 803 in which the radiation source, such as the radiationsource 103 (FIG. 1) or the radiation source 203 (FIG. 2) is activated.In the SSTS 100, the radiation source 103 is activated either by thefoot pedal 109 or the user controls 113. In the SSTS 200, the radiationsource 200 is activated by the computing system 209, either in responseto user input on the keyboard 217 or mouse 209 or in response to a timer(not shown) that periodically updates a sponge count produced by theSSTS 200 and displayed on the display 215. In another embodiment of theSSTS 200, the radiation source 203 may be activated in response to theweight sensor in the platform 221 so that information displayed on thedisplay 215 is updated in real time. Control then proceeds to a CountRadiopaque Objects step 805.

In step 805, a sensor detects the number of radiopaque objects such asobject 301 (FIG. 3) in the surgical sponges such as surgical sponge 111in the container 201 by detecting the scanning beam generated by eitherradiation source 103 or 203. A signal from the sensor is transmitted tothe logic (SSTS 100) or the computing system 209 via the connection 207(SSTS 200), enabling the logic or computing system 209 to calculate thespecific number of sponges in the container 101 or 201, respectively. Inone embodiment of the invention, surgical sponges of differing sizes ortypes each contain a radiopaque object of a size or shape thatcorresponds to the different size sponges. Using the different sizes orshapes, the logic or computing system 209 processes the signal from thesensor to determine not only a count but a specific count for each ofthe different sizes or types of sponges.

Following step 805, process 800 proceeds to a Fluid MeasurementRequested step 807 in which, using the SSTS 200 as an example, the SSTS200 determines whether information on the collective weight of thesponges in the container 201 is requested. If a weight measurement isnot requested, then control proceeds to a Display Results step 815, inwhich the specific number of sponges calculated in step 805 is displayedon the display 215. In an alternative embodiment, rather than using thedisplay 215, the number may simply be rendered in a display device suchas a light emitting diode (LED) device on the platform 221 itself. Ofcourse, if the SSTS 200 does not include a weight sensor in the platform221, control proceeds directly from step 805 to step 815. If in step807, process 800 determines that a fluid measurement step is required orrequested, then control proceeds to a Weigh Container step 709, in whicha weight sensor in the platform sends a signal representing the weightof the container 201 and its contents via the connection 207 to thecomputing system 209. Control then proceeds to a Subtract Sponge Weightstep 811 in which the computing system 209 employs the weight signal, inconjunction with the count signal, to calculate a tare weight for thecontainer 201 and its contents. Control then proceeds to a CalculateFluids step 813 in which the computing system 209 determines, based uponthe tare and the weight signal from the platform 201, the amount offluids that have been absorbed by the sponges in the container 201.Control then proceeds to the Display Results step 815 in which both thesponge count and the fluid weight is displayed on the display 215 orother display device, such as the display 107 in the case of the SSTS100. Following step 815, control proceeds to an End Scan step 817 inwhich processing is complete. Of course, as explained above, process 800may execute periodically or be initiated by a user.

While various embodiments of the application have been described, itwill be apparent to those of ordinary skill in the art that many moreembodiments and implementations are possible that are within the scopeof this invention. Accordingly, the invention is not to be restrictedexcept in light of the attached claims and their equivalents.

1. A trackable, surgical sponge, comprising: a surgical sponge; and apassive, radiographically detectable object affixed to the surgicalsponge, wherein the radiographically detectable object appears to havesubstantially the same outside dimensions when viewed from differentangles.
 2. The trackable, surgical sponge of claim 1, wherein acharacteristic feature of the radiographically detectable objectcorresponds to a particular type of surgical sponge.
 3. The trackable,surgical sponge of claim 2, wherein the characteristic feature of theradiographically detectable object is related to the size of theradiographically detectable object.
 4. The trackable, surgical sponge ofclaim 2, wherein the characteristic feature of the radiographicallydetectable object is related to a type of material of theradiographically detectable object.
 5. The trackable, surgical sponge ofclaim 1, wherein the radiographically detectable object is spherical. 6.The trackable, surgical sponge of claim 1, wherein the radiographicallydetectable object is non-spherical.
 7. The trackable, surgical sponge ofclaim 1, wherein the radiographically detectable object is metal.
 8. Thetrackable, surgical sponge of claim 1, wherein the radiographicallydetectable objects comprise a non-metallic radiopaque substance.
 9. Thetrackable, surgical sponge of claim 8, wherein the non-metallicradiopaque substance is barium sulfate encased within anon-water-soluble material.
 10. A method of tracking and countingsurgical sponges, comprising the steps of: affixing a plurality ofradiopaque objects in a plurality of surgical sponges, wherein eachsurgical sponge has one (1) radiopaque object; scanning a containercontaining a number of the plurality of surgical sponges that have beenemployed in a surgical field; determining, based upon the number ofradiopaque objects detected in the scanning step, the number of surgicalsponges in the container; and reporting the number of surgical spongesin the container.
 11. The method of claim 10, wherein the plurality ofsurgical sponges includes surgical sponges of at least two differentsizes and the corresponding radiographically detectable objects includeobjects of at least two different sizes and the size of each particularradiographically detectable object corresponds to the size of thecorresponding surgical sponge.
 12. The method of claim 10, furthercomprising the steps of: calculating an amount of fluid contained in thesurgical sponges in the container by subtracting a calculated weigh ofthe surgical sponges in the container.
 13. A surgical sponge,comprising: a tightly-woven, absorbent fabric; and a passive,radiographically detectable object securely affixed to the fabric,wherein the radiographically detectable object appears to havesubstantially the same outside dimension when viewed from differentangles.
 14. The surgical sponge of claim 13, wherein the sponge is oneof at least two different types of sponges and correspondingradiographically detectable objects include objects of at least twodifferent types, the type of each particular radiographically detectableobject corresponding to the type of the corresponding surgical sponge.15. The surgical sponge of claim 14, wherein the types ofradiographically detectable objects are related to the size of theradiographically detectable objects.
 16. The surgical sponge of claim14, wherein the types of radiographically detectable objects are relatedto a feature other than size of the radiographically detectable objects.17. The surgical sponge of claim 13, wherein the radiographicallydetectable objects are spherical.
 18. The surgical sponge of claim 13,wherein the radiographically detectable objects are non-spherical. 19.The surgical sponge of claim 13, wherein the radiographically detectableobject is metal.
 20. The surgical sponge of claim 13, wherein theradiographically detectable object is a non-metallic radiopaquesubstance.